Lab Specialist

Lab Specialist

The Laboratory Specialist is responsible for executing and supporting laboratory projects and routine operations in a regulated cGMP environment. This role supports activities such as equipment qualification, method transfer, method validation, laboratory investigations, documentation updates, and continuous improvement initiatives. The position collaborates cross-functionally with Quality, Operations, Engineering, and global laboratory teams to ensure compliant, efficient, and reliable laboratory performance.

Essential Duties and Responsibilities:

• Plan and execute local laboratory projects including quality and safety initiatives.
• Participate in local and global laboratory projects and represent the Kinston Laboratory.
• Coordinate and execute internal equipment qualifications, methods transfers and methods validations.
• Prepare capital expenditure reports for the acquisition of new lab equipment.
• Drive assigned projects from protocol development through execution, data analysis, and final report completion.
• Perform laboratory investigations for deviations, out-of-specification (OOS), and nonconformance events.
• Support routine laboratory testing and review laboratory documentation for accuracy, completeness, and compliance.
• Support in training laboratory personnel on methods, procedures, equipment, and good documentation practices.
• Prepare, review, and revise laboratory procedures, test methods, protocols, and work instructions to maintain cGMP compliance.
• Maintain current knowledge of applicable cGMP requirements, data integrity expectations, and internal quality procedures.
• Collaborate effectively across functions while working independently with a high level of initiative, adaptability, accountability, and a positive attitude.
• Support implementation and evaluation of new laboratory technologies, methods, and process improvements.
• Perform other duties as assigned.

Education: Masters degree in Science related discipline preferred. 3-5 years of professional experience in a lab environment or similar role. Experience with Electronic Document Management Systems. Experience with validations and project management.

Work Experience: Minimum 3 years 3 -5 years of professional experience in a lab environment required and Experience in pharmaceutical/medical device field and implementing laboratory training programs required.

Preferred Knowledge, Skills and Abilities:

• Proficiency in English
• Background in cGMP related industry
• Background in Project Management.
• Strong competence in computer systems.
• Good verbal and written communications skills.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Challenge processes remain open to ideas and changes, to continuously improve and seek better alternatives and drive change.
• Able to comply with the company's safety policy at all times.
• Able to comply with the company's quality policy at all times.

Additional Requirements:

• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Use written and oral communication skills
• Read and interpret data, information and documents
• Analyze and solve problems
• Observe and interpret situations
• Learn and apply new information or new skills

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.